Fentanyl

What Is Fentanyl (Duragesic)?

Fentanyl is the generic form of the brand-name drug Duragesic, a prescription opioid (narcotic) drug used to treat chronic, "around-the-clock" pain.

It should be used only by people who are "opioid-tolerant," or who are already taking opioid pain medications, such as morphine and oxycodone, regularly.

Fentanyl is in a class of drugs called opioid analgesics, which work by binding to nervous system proteins called opioid receptors, thereby blocking the transmission of pain signals to the brain.

Duragesic is a transdermal (through-the-skin) patch. Fentanyl is also sold as a lozenge (under the brand Actiq), a tablet that goes under the tongue (Abstral), a film that's applied to the inner lining of the cheek or lip (Onsolis), a tablet that goes between the gum and cheek (Fentora) a nasal spray (Lazanda), a sublingual tablet (Abstral), and a sublingual spray (Subsys).

The Food and Drug Administration (FDA) first approved fentanyl, which is produced by Johnson & Johnson, in 1968.

Over the years, Johnson & Johnson has issued several recalls of its Duragesic pain-relief skin patches.

In 2004 and 2008, the company recalled some of its patches because of damage that could have caused the medication to leak potentially fatal fentanyl gel.

In 2012, Johnson & Johnson recalled more than 53,000 Duragesic patches after fentanyl crystals were found in a patch (the drug is supposed to be completely dissolved).

Fentanyl Abuse

Fentanyl use can lead to addiction, abuse, and misuse, even at the recommended doses — this risk is higher for people with a personal or family history of substance abuse or mental illness.

Fentanyl is almost 100 times more potent than morphine, but the drug is designed to deliver small amounts of fentanyl each hour over an extended period of time.

When ingested, however, the Duragesic patch can deliver its entire dose all at once, increasing the risk of an overdose. In 2008, a study in the Journal of Forensic Sciences reviewed seven case reports of oral abuse of Duragesic and found that fentanyl overdose caused or contributed to the deaths of the persons in each case.

Fentanyl Withdrawal

As with other addictive drugs, stopping fentanyl suddenly may result in withdrawal symptoms, including:

Fentanyl Warnings

Fentanyl carries a black-box warning about its potential for addiction, abuse, misuse, and its associated risk of fatal overdose. People who are accidentally exposed to fentanyl, particularly children, are especially vulnerable to a fatal overdose.

Fentanyl should be used only by people with chronic pain who are opioid tolerant.

You should not use it to treat mild, post-operative, intermittent, or short-term pain. People with significant respiratory problems, acute or severe asthma, paralytic ileus (an obstruction of the intestine), or a known sensitivity to fentanyl shouldn't take fentanyl.

People who are non-opioid tolerant shouldn't take fentanyl, because the drug carries a high risk of life-threatening respiratory depression (low breathing rate). Respiratory depression may also occur in opioid-tolerant people, even when the drug is used as directed, especially when first going on fentanyl or increasing the dosage.

If you're older, debilitated, or have a wasting syndrome called cachexia, you're more likely to experience respiratory depression.

Potentially fatal respiratory depression may also occur if you use fentanyl while taking cytochrome P450 3A4 (CYP3A4) inhibitors, such as ritonavir (Norvir), nefazodone (Serzone), nelfinavir (Viracept), and while drinking grapefruit juice.

Using fentanyl while taking central nervous system depressants, such as sedatives, hypnotics, alcohol, and other opioids, can cause abnormally low blood pressure, profound sedation, coma, respiratory depression, and death.

When using fentanyl, don't expose the patch or surrounding area to direct external heat sources such as saunas, hot tubs, and heating pads, as this may increase your body's rate of fentanyl absorption, possibly leading to a fatal overdose.

You're also at risk for increased fentanyl exposure if you have a fever or an increased core body temperature, such as from strenuous exercise.

Pregnancy and Fentanyl

Prolonged use of opioid analgesics (painkillers), including fentanyl, during pregnancy can produce drug dependence in newborns. It can also result in neonatal opioid withdrawal syndrome, which has various symptoms and signs, including:

Poor feeding and irritability

Diarrhea

Tremor and seizures

Rigidity

Fentanyl is an FDA Pregnancy Category C drug; this means that animal studies have shown an "adverse" effect on the fetus, and so there's a possibility the opioid may harm developing human fetuses.

It should only be used during pregnancy if the potential pain-relieving benefits outweigh the potential risks to the fetus.

Fentanyl shouldn't be used during or immediately before labor because opioids can cross the placenta and potentially cause respiratory depression in newborns. The drug may also prolong labor.

Because fentanyl is excreted in breast milk, do not use fentanyl if you're breastfeeding.

Fentanyl FAQ

Q: I was prescribed fentanyl patch (25) for excruciating back pain, but after reading all of the side effects from the included pamphlet, I am actually afraid to use it. The first thing that struck me was that it can cause "fatal breathing problems." It also went on to say that it is more addicting than morphine, and if you have heart disease and hypothyroidism (of which I have both), I should not use it. Please give me some ideas on whether or not I should use the fentanyl patch (25).

A: The problems that you noted are in the literature. I would discuss this more with your health care provider for peace of mind before trying the patch. I would ask him if there is any other type of medication that you could use to help with the pain. Be sure to bring the pamphlet with you which contains this information.

Q: My doctor put me on fentanyl patches 25 mcg. I have been on Lortab 10mg for many years which I tolerate well. I've only been on the patch 72 hours but I feel tired. Will I adapt to this medicine and get over this feeling? I am a 65 year old male who likes to stay active despite my pain and do not like this feeling!

A: Fentanyl (Duragesic) skin patches are used to relieve moderate to severe pain that is expected to last for some time, that does not go away, and that cannot be treated with other pain medications. Fentanyl skin patches are only used to treat people who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. Side effects of Fentanyl include headache, dizziness, confusion, weakness, drowsiness and constipation. If you take Fentanyl on a regular basis, these effects usually wear off 1-2 weeks after you start taking the medication or increase your dose. For more information on Fentanyl see http://www.everydayhealth.com/drugs/fentanyl
Lori Poulin, PharmD

Q: I have pain, and my doctor prescribed fentanyl patches 25 mcg. I've been on lortab 10 mg for many years, which I tolerate well. I've only been on the patch 72 hours, but i feel tired. I like to stay active despite my pain. Will I adapt to this medicine and get through this feeling?

A: Fentanyl (Duragesic) skin patches are used to relieve moderate to severe pain that is expected to last for some time, that does not go away, and that cannot be treated with other pain medications. Fentanyl skin patches are only used to treat people who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. Side effects of fentanyl include headache, dizziness, confusion, weakness, drowsiness and constipation. If you take fentanyl on a regular basis, these effects usually wear off 1-2 weeks after you start taking the medication or increase your dose. You may also find helpful information on fentanyl at http://www.everydayhealth.com/drugs/fentanyl Lori, PharmD

Q: Can the Duragesic patch cause intestinal obstruction?

A: The Duragesic skin patch contains fentanyl, a narcotic (or opioid) for the treatment of moderate to severe chronic pain. As with all narcotic pain relievers, fentanyl can be habit-forming and should only be used by the person for whom it was prescribed. According to the package insert, the most significant side effect is the potential for respiratory depression, which can lead to weak and shallow breathing. If this occurs, the patch should be removed and you should contact your doctor. The most common side effects include nausea, vomiting, stomach pain, constipation, gas, dizziness, drowsiness, anxiety, sleep problems (insomnia), muscle stiffness, back pain, itching, blistering, redness, or swelling where the patch was worn, and increased sweating or urinating. Because Duragesic can cause significant drowsiness, it is important to understand how the medication affects you before driving or operating machinery or performing other tasks that require mental alertness. All narcotic pain relievers can cause constipation because of their effects on gastrointestinal motility and secretions. Many patients require a bowel regimen consisting of a stool softener and mild stimulant throughout therapy with narcotic pain relieves. If you do not have a bowel movement for three days, an enema or suppository should be administered to prevent impaction. For more information, please consult your health care provider and visit http://www.everydayhealth.com/drugs/duragesic-12. Michelle McDermott, PharmD

Q: How should fentanyl patches be administered?

A: Fentanyl skin patches are used in the treatment of persistent moderate to severe chronic pain. Fentanyl is an opioid analgesic, or pain killer. It works by changing the way the brain and nervous system respond to pain. Fentanyl patches are only for people whose pain cannot be controlled by other pain medications including oral opioids. Fentanyl patches are only indicated to be used in people who are already receiving opioid pain medications. Fentanyl patches are used for pain relief that is needed around the clock, not on an as needed basis. Fentanyl patches can be habit forming. Some of the common side effects associated with fentanyl patches include confusion, headache, drowsiness, dizziness, slowed breathing and heart rate, constipation and dehydration. Here are some suggestions for applying the fentanyl patch according to the prescribing information. Â· The patch should be applied to flat, non-irritated skin -- like the back, flank, chest or upper arm Â· If there is hair on the area, remove by clipping, not shaving Â· If the skin needs to be cleaned prior to application, use clear water Â· Do not use lotions, oils, soaps, or alcohol on the skin that may irritate it or change its characteristics Â· Allow the skin to dry completely before applying the patch Â· Use the palm of the hand to press and hold down the patch on the skin for 30 seconds, making sure contact is complete, especially around the edges If there is a problem with the patch adhering to the skin, a transparent adhesive film dressing, like Bioclusive or Askina Derm, may be placed over the patch. This may not be a complete list of side effects or directions for patch application. It is important to speak with your health care provider in regards to appropriate dosing and application of the fentanyl patch, and follow the complete directions provided with your prescription. Kristen Dore, PharmD

Q: How long does fentanyl stay in the body?

A: Fentanyl is a potent pain relieving medication delivered topically through a skin patch. According to the prescribing literature, once the Fentanyl patch is removed, the concentration of Fentanyl in the blood stream is reduced gradually. It can take approximately 20 to 27 hours for the blood concentration of Fentanyl patch to be decreased by 50% once the patch is removed. Therefore, it could possibly take 48 to 72 hours for the body to completely eliminate Fentanyl from the blood stream. The breakdown of medications is dependent on kidney function, liver function, other medications, age, medical conditions, health status, the use of herbal products and other nonprescription products. The manufacturer recommends that a patient discontinuing the patch should be monitored for at least 24 hours following the removal of the patch for any adverse effects. Consuelo Worley, RPh, MS

Q: How do you stop taking a fentanyl patch?

A: Fentanyl (Duragesic) is classified as an opioid analgesic medication. Fentanyl is approved for the treatment of persistent, moderate to severe pain that requires continuous, around-the-clock opioid administration for a prolonged period of time and for pain that can't be controlled with other medications such as nonsteroidal anti-inflammatory medications, opioid combination medications or immediate-release opioids. If you feel that you should not be using fentanyl patches any longer, it is important that you talk to your physician. You should not stop the medication or decrease the dose of the medication without first talking to your physician. According to the prescribing information for fentanyl, if the medication is to be stopped, your physician may prescribe a tapering down of your fentanyl dose. Abruptly discontinuing the medication can result in withdrawal symptoms. There are specific directions and charts that your physician can utilize to convert a patient to different pain medications if this is required. Tapering of dosages and converting patients to different pain medications is done at the discretion of your physician. Your physician can provide you specific directions on how to stop taking fentanyl patches, if this is an appropriate therapeutic decision. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jen Marsico, RPh

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